Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) After Renal Transplant

Last updated: July 25, 2025
Sponsor: Weill Medical College of Cornell University
Overall Status: Completed

Phase

4

Condition

Hiv Infections

Treatment

BIC/F/TAF 50Mg-200Mg-25Mg Tablet

BIKTARVY 50Mg-200Mg-25Mg Tablet

Clinical Study ID

NCT04530630
20-01021384
  • Ages > 18
  • All Genders

Study Summary

This is an open-label study, where participants will be switched from their current HIV medication to the study drug, BIC/F/TAF. Open-label means both the investigator and the participant will know what drug will be given. Participants will be followed for 48 weeks in order to monitor the efficacy, safety and tolerability of BIC/F/TAF. The investigator hypothesizes that BIC/F/TAF will be an important addition to the management of HIV-positive post renal transplant patients, especially since it is a one pill daily dosing regimen, thereby decreasing the pill burden in this population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years old on day of signing informed consent

  • Positive for human immunodeficiency virus (HIV)

  • Received a previous renal transplant

  • Must have controlled HIV infection for at least 3 months prior to enrollment

Exclusion

Exclusion Criteria:

  • Received a kidney from a donor who was HIV positive (unless a false positive)

  • Currently taking BIC/F/TAF for treatment of HIV

  • Has allergies to any of the HIV medications in BIC/F/TAF (bictegravir,emtricitabine, or tenofovir alafenamide)

  • Currently taking dofetilide or rifampin

  • Is pregnant or breastfeeding

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: BIC/F/TAF 50Mg-200Mg-25Mg Tablet
Phase: 4
Study Start date:
November 09, 2020
Estimated Completion Date:
August 28, 2024

Connect with a study center

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

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